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Recruiting NCT05340062

Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age

— Observational Intracranial Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: bedside sonography.
Who it may be relevant to
Registry conditions: Intracranial Hypertension. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Accuracy of Intracranial Pressure Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age

Overview

An increase of intracranial pressure (ICP) is an important cause of secondary brain damage. The gold standard for measuring ICP is represented by invasive positioning of intracranial ICP devices. The most used non-invasive methods (nICP) are obtained through bed-side ultrasound, routinely used in the management of children in Pediatric Intensive Care: arterial Trancranial Doppler (TCD) and ultrasound measurement of the diameter of the optic nerve sheath (ONSD ). In this study it is proposed to compare the measurement of nICP obtained by TCD and ONSD versus the measurement obtained by the invasive monitoring (iICP) already present.

Detailed description

An iIncrease in intracranial pressure (ICP) is an important cause of secondary brain damage. The cerebral perfusion pressure (CPP), defined as the mean arterial pressure value (MAP) minus the ICP value (CPP = MAP-ICP), represents the pressure gradient that is responsible for cerebral flow. The gold standard for measuring ICP is represented by invasive methods that are intra-parenchymal or intra-ventricular catheters positions by neurosurgeons. The placement of these catheters can cause complications, mainly bleeding and infections.

The most used non-invasive (nICP) methods are obtained through a medical device such as bed-side ultrasound, routinely used in the management of children in Pediatric Intensive Care: arterial Trancranial Doppler (TCD) and ultrasound measurement of the diameter of the optic nerve sheath (ONSD ).

Arterial TCD is one of the most studied methods in adults for the non-invasive estimation of ICP. Formulas derived from the measurement of cerebral flow velocities (VF) such as the Pulsatility Index (PI) and the formula based on the Diastolic Flow Rate (FVdICP) have been shown to have a correlation with the iICP. According to the literature, a PI\> 1 is associated with an ICP value\> 20 mmHg. Schmitd, Czosnyka et al. subsequently proposed a new formula for the non-invasive measurement of CPP and therefore of ICP (FVdICP), demonstrating the accuracy of CPP measured with the invasive technique The ONSD is a rapid and repeatable method for making a rapid diagnosis of increased ICP not only in adults but also in children, considering the diameter of the optic nerve sheath equal to 4.5 mm in children as the upper limit of the norm. 1 year of age and 4 mm in children under 1 year.

In this study it is proposed to compare the measurement of nICP obtained with the TCD and with the ONSD versus the measurement obtained by the invasive monitoring (iICP) already present.

Interventions

  • Device bedside sonography
    TCD and ONSD sonography twice a day per 2 days

Primary outcome measures

  • comparison between ICP and nICP (measured by TCD) [Time frame: within 48 hours after the invasive ICP placement]
  • comparison between ICP and nICP (measured by TCD) [Time frame: within 48 hours after the invasive ICP placement]
  • comparison between ICP and nICP (measured by TCD) [Time frame: within 48 hours after the invasive ICP placement]
  • comparison between ICP and nICP (measured by TCD) [Time frame: within 48 hours after the invasive ICP placement]
Secondary outcome measures (3)
  • comparison between ICP and nICP (measured by ONSD) [Time frame: within 48 hours after the invasive ICP placement]
  • interrater reliability for TCD measurement [Time frame: within 48 hours after the invasive ICP placement]
  • interrater reliability for ONSD measurement [Time frame: within 48 hours after the invasive ICP placement]

Eligibility criteria

Inclusion criteria

  • invasive ICP placement

Exclusion criteria

  • cranial base fracture
  • absent informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Italy · 6 centers
  • PICU IRCSS Sant'Orsola Malpighi — Bologna
  • PICU Spedali Civili BRescia — Brescia
  • PICU Ospedale Mayer — Florence
  • PICU Ospedale Gaslini — Genova
  • PICU University Hospital Padova — Padova
  • PICU Università Cattolica — Roma

Publications

  • Czosnyka M, Pickard JD. Monitoring and interpretation of intracranial pressure. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):813-21. doi: 10.1136/jnnp.2003.033126. PMID 15145991
  • Kochanek PM, Tasker RC, Carney N, Totten AM, Adelson PD, Selden NR, Davis-O'Reilly C, Hart EL, Bell MJ, Bratton SL, Grant GA, Kissoon N, Reuter-Rice KE, Vavilala MS, Wainwright MS. Guidelines for the Management of Pediatric Severe Traumatic Brain Injury, Third Edition: Update of the Brain Trauma Foundation Guidelines, Executive Summary. Neurosurgery. 2019 Jun 1;84(6):1169-1178. doi: 10.1093/neuros PMID 30822776
  • Anderson RC, Kan P, Klimo P, Brockmeyer DL, Walker ML, Kestle JR. Complications of intracranial pressure monitoring in children with head trauma. J Neurosurg. 2004 Aug;101(1 Suppl):53-8. doi: 10.3171/ped.2004.101.2.0053. PMID 16206972
  • Schmidt EA, Czosnyka M, Gooskens I, Piechnik SK, Matta BF, Whitfield PC, Pickard JD. Preliminary experience of the estimation of cerebral perfusion pressure using transcranial Doppler ultrasonography. J Neurol Neurosurg Psychiatry. 2001 Feb;70(2):198-204. doi: 10.1136/jnnp.70.2.198. PMID 11160468
  • Malayeri AA, Bavarian S, Mehdizadeh M. Sonographic evaluation of optic nerve diameter in children with raised intracranial pressure. J Ultrasound Med. 2005 Feb;24(2):143-7. doi: 10.7863/jum.2005.24.2.143. PMID 15661943
  • O'Brien NF, Reuter-Rice K, Wainwright MS, Kaplan SL, Appavu B, Erklauer JC, Ghosh S, Kirschen M, Kozak B, Lidsky K, Lovett ME, Mehollin-Ray AR, Miles DK, Press CA, Simon DW, Tasker RC, LaRovere KL. Practice Recommendations for Transcranial Doppler Ultrasonography in Critically Ill Children in the Pediatric Intensive Care Unit: A Multidisciplinary Expert Consensus Statement. J Pediatr Intensive Car PMID 33884214

Identifiers

NCT: NCT05340062 · 5210/AO/21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗